Evidence map›Paper›PMID 32175197›Full record

ArticleCureus2018

The Photodynamic Bone Stabilization System in the Treatment of Humerus Fractures: A Prospective Clinical Trial.

Paul Vegt, Jan Verbruggen, Thomas Gausepohl, Jos P Vroemen, Walter Schafer, Dietmar Pennig, Jeffrey M Muir

Open access · diamondAbstract read
In one paragraph

Article in Cureus, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 4 countries.

Paul VegtSurgery, Albert Schweitzer Hospital, Dordrecht, NLD.
Jan VerbruggenSurgery, University Hospital Maastricht, Maastricht, NLD.
Thomas GausepohlTrauma Surgery, Lahn-Dill Kliniken, Klinikum Wetzlar, Marl, DEU.
Jos P VroemenSurgery, Amphia Hospital, Breda, NLD.
Walter SchaferClinic for Orthopedics, Kreiskrankenhaus Gummersbach, Gummersbach, DEU.
Dietmar PennigSurgery, St. Vinzenz Hospital Gmbh, Cologne, DEU.
Jeffrey M MuirClinical Research, Telos Partners, Llc., Toronto, CAN.
HealthPartners · USUniversity Hospital Cologne · DEKlinikum Vest · DEKreiskrankenhaus Gummersbach · DEMaastricht University Medical Centre · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Fractures of the proximal humerus are among the most common long-bone fractures and present unique challenges to surgeons. Traditional internal fixation methods, such as intramedullary nails, are associated with drawbacks such as an inability to fully fill the trabecular space and a limited ability to utilize supplemental hardware in many cases. We evaluated the safety and effectiveness of a novel fracture fixation device that utilizes a light-cured monomer to stabilize the fracture in a cohort of patients suffering from humerus fractures. Methods We prospectively collected data from patients being treated surgically for humerus fractures. Fractures were treated using the photodynamic bone stabilization system (PBSS) consisting of a balloon and light-cured monomer. Patients were evaluated at 7-14, 30, 60, 90, 180, and 360 days post-procedure. Primary outcomes included normal and complete radiographic fracture healing. Secondary outcomes included pain (via visual analog scale), function (via the disability of the arm, shoulder, and hand (DASH) and constant shoulder scales), and the rate of complications. Results A total of 33 patients were included in the intent-to-treat analysis (mean age: 76.6 yrs). Of these patients, 88% demonstrated normal radiographic healing at their 90-, 180-, and 360-day visits. Complete radiographic healing was observed in 81%, 88%, and 96% of patients at 90, 180, and 360 days, respectively. Pain scores decreased significantly at day seven when compared with baseline (28.2+20.9 vs.53.6+32.2, p<0.001) and continued to decrease at the 90-day (24.7+15.5, p<0.001), 180-day (17.8+12.5, p<0.001) and 360-day (6.6+6.7, p<0.001) evaluations. DASH scores demonstrated statistically significant improvements over baseline (65.5+31.5) at 90 (37.0+14.9, p<0.001), 180 (30.6+15.7, p<0.001), and 360 days (23.9+15.0, p<0.001) post-procedure. The procedure-related event rate was 36.4%, with 5 (11.4%) device-related adverse events reported at the one-year follow-up. Conclusions Our study demonstrates the ability of a novel internal fixation device to safely and effectively treat fractures of the humerus in the elderly population.

Indexed as

internal fixationlong bone fracturephotodynamic bone stabilization systempolymer

Identifiers

PMID32175197
PMCPMC7053794
OpenAlexW2808258718

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.